UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025847 |
|---|---|
| Receipt number | R000029721 |
| Scientific Title | Endobiliary Radiofrequency Ablation Using a New Catheter for Malignant Biliary Strictures: A Prospective Multicenter Study |
| Date of disclosure of the study information | 2017/01/25 |
| Last modified on | 2017/01/25 20:40:31 |
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Basic information
Public title
Endobiliary Radiofrequency Ablation Using a New Catheter for Malignant Biliary Strictures: A Prospective Multicenter Study
Acronym
Endobiliary radiofrequency ablation for malignant biliary strictures
Scientific Title
Endobiliary Radiofrequency Ablation Using a New Catheter for Malignant Biliary Strictures: A Prospective Multicenter Study
Scientific Title:Acronym
Endobiliary radiofrequency ablation for malignant biliary strictures
Region
| Asia(except Japan) |
Condition
Condition
Malignant biliary strictures by bile duct cancer, gallbladder cancer, or pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the safety and efficacy of endobiliary radiofrequency ablation (RFA) by using a new catheter in patients with malignant biliary strictures.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of early adverse events within 30 days after endobiliary radiofrequency such as hemobilia, bile duct perforation, pancreatitis, bleeding, cholangitis, perforation, or cholecystitis.
Key secondary outcomes
Late adverse events after 30 days after endobiliary radiofrequency, stent patency of biliary metallic stent after endobiliary radiofrequency ablation, and patient survival after endobiliary radiofrequncy ablation.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Endobiliary radiofrequency ablation by using a new catheter and biliary metallic stenting through ERCP
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 19 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) More than 19 in age
2) Extrahepatic malignant biliary stricture that was histophathologically or clinically confirmed
3)Unresectable or inoperable due to comorbidity or refusal of operation
4) More than 3 months of predictive survival
Key exclusion criteria
1) Contraindications for ERCP
2) Uncontrolled coagulopathy: PT-INR > 1.5 (normal 0.85 - 1.25) or platelet count < 60,000/mm3 (normal 150,000 - 450,000/mm3)
3) Previously operation of bile duct
4) Impossible to access to the ampulla of Vater or failed selective biliary cannulation
5) Pregnant or breastfeeding women
6) Refusal to the study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hyun Jong Choi |
Organization
SoonChunHyang University School of Medicine
Division name
Digestive Disease Center and Research Institute, Department of Internal Medicine
Zip code
Address
170 Jomaru-ro, Wonmi-gu, Bucheon 14584
TEL
+82-32-621-5211
joseph@schmc.ac.kr
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hyun Jong Choi |
Organization
SoonChunHyang University School of Medicine
Division name
Digestive Disease Center and Research Institute, Department of Internal Medicine
Zip code
Address
170 Jomaru-ro, Wonmi-gu, Bucheon 14584
TEL
+82-32-621-5211
Homepage URL
joseph@schmc.ac.kr
Sponsor or person
Institute
Digestive Disease Center and Research Institute, Department of Internal Medicine, SoonChunHyang University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Digestive Disease Center and Research Institute, Department of Internal Medicine, SoonChunHyang University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Date of protocol fixation
| 2016 | Year | 03 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 25 | Day |
Last modified on
| 2017 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029721
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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